Preterm LabourPROCERNCT07307092
Intramuscular vs Rectal Progesterone in Preventing Preterm Labour After Cervical Cerclage
A study testing Intramuscular Progesterone and Rectal Progesterone in people with Preterm Labour and Cervical Insufficiency, run by Hina Mukhtar at 1 site in Pakistan.
Trial summary
Preterm labour is a major cause of neonatal morbidity and mortality worldwide. Progesterone supplementation is known to help reduce the risk of preterm birth in high-risk women. This randomized controlled trial compared the effectiveness of intramuscular progesterone and rectal progesterone in preventing preterm… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preterm Labour, Cervical Insufficiency, Pregnancy, High-Risk
- What is being tested?
- Intramuscular Progesterone and Rectal Progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 820 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Oct 2021to 25 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women aged 18-45 years
- Singleton pregnancy
- Gestational age between 16 and 24 weeks at enrollment
- Diagnosed with cervical insufficiency and scheduled for or recently undergone cervical cerclage
- Willing to receive progesterone therapy and provide written informed consent
Who cannot join
- Multiple pregnancy
- Known fetal anomalies
- Severe maternal comorbidities (e.g., hypertension, diabetes, cardiac disease)
- History of allergy or hypersensitivity to progesterone or related compounds
- Contraindications to progesterone use
- Women who declined to participate or were non-compliant with follow-upInclusion Criteria:
- -
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intramuscular Progesterone and Rectal Progesterone in the Prevention of Preterm Labour in Patients Undergoing Cervical Cerclage: A Randomized Controlled Trial
Preterm labour is a major cause of neonatal morbidity and mortality worldwide. Progesterone supplementation is known to help reduce the risk of preterm birth in high-risk women. This randomized controlled trial compared the effectiveness of intramuscular progesterone and rectal progesterone in preventing preterm labour among pregnant women who had undergone cervical cerclage. The study aimed to determine which route of progesterone administration provides better pregnancy prolongation and improved neonatal outcomes.
Read the detailed description
Background:
Preterm labour remains one of the leading causes of perinatal mortality and long-term neonatal complications. Cervical insufficiency, often managed by cervical cerclage, is a recognized risk factor for preterm birth. Progesterone supplementation helps maintain uterine quiescence and cervical integrity, but the optimal route of administration after cerclage is not well established.
Objective:
To compare the efficacy of intramuscular progesterone versus rectal progesterone in preventing preterm labour among women who underwent cervical cerclage.
Methods:
This single-centre, randomized controlled trial was conducted in the Department of Obstetrics \& Gynecology, Bahawal Victoria Hospital, Bahawalpur, Pakistan. Eligible women with singleton pregnancies who had undergone cervical cerclage were randomly assigned to receive either weekly intramuscular progesterone (250 mg) or daily rectal progesterone suppositories (400 mg) from 16 to 36 weeks of gestation. The primary outcome was the incidence of preterm labour before 37 weeks. Secondary outcomes included gestational age at delivery, neonatal birth weight, NICU admission, and maternal side effects.
Significance:
This study provides evidence on the comparative effectiveness of two commonly used routes of progesterone administration in women with cerclage, aiming to identify the safer and more convenient regimen for prolonging pregnancy and improving neonatal outcomes.
- Conditions
- Preterm Labour, Cervical Insufficiency, Pregnancy, High-Risk
- Being tested
- Intramuscular Progesterone, Rectal Progesterone
- Keywords
- Interventions, Population, Study design, Clinical focus
- Medical subject headings
- Obstetric Labor, Premature, Uterine Cervical Incompetence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular ProgesteroneDrug
Hydroxyprogesterone caproate 250 mg administered intramuscularly once weekly from 16 to 36 weeks of gestation following cervical cerclage. Used to maintain uterine quiescence and prevent preterm labour.
Rectal ProgesteroneDrug
Micronized progesterone 400 mg suppository administered rectally once daily from 16 to 36 weeks of gestation following cervical cerclage. Intended to provide sustained progesterone support and prevent preterm labour.
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular Progesterone Group | Experimental | Participants in this group received intramuscular progesterone (hydroxyprogesterone caproate) 250 mg once weekly, starting from 16 weeks until 36 weeks of gestation, following cervical cerclage. The injections were administered in the gluteal region under aseptic conditions. The purpose of this intervention was to maintain uterine quiescence and reduce the risk of preterm labour in high-risk pregnancies after cerclage. Receives: Drug: Intramuscular Progesterone; Drug: Rectal Progesterone |
| Rectal Progesterone Group | Experimental | Participants in this group received rectal progesterone suppositories 400 mg once daily, starting from 16 weeks until 36 weeks of gestation, following cervical cerclage. The suppositories were self-administered at bedtime. The aim of this intervention was to provide sustained progesterone support for maintaining uterine relaxation and reducing the risk of preterm labour after cerclage. Receives: Drug: Intramuscular Progesterone; Drug: Rectal Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Preterm Birth (<37 Weeks)
Measured: 16-36 weeks until delivery
Secondary outcomes (5)
Gestational Age at Delivery
Measured: At delivery
Neonatal Birth Weight
Measured: At birth
Apgar Scores at 1 and 5 Minutes
Measured: Immediately post-delivery
NICU Admission Rate
Measured: Within 24 hours of birth
Maternal Adverse Effects
Measured: During treatment period (16-36 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start26 Oct 2021
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LabourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hina Mukhtar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hina Mukhtar, Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan
- Investigators
- Hina Mukhtar, MBBS, Principal investigator, CMIS Bahawalpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307092
- Sponsor's protocol ID
- CMH-OBG-RCT-2025-01
- Acronym
- PROCER
- Status last verified
- Dec 2025
- First submitted
- 13 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intramuscular Progesterone and Rectal Progesterone in the Prevention of Preterm Labour in Patients Undergoing Cervical Cerclage: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07307092
- Acronym / sponsor ID
- PROCER / CMH-OBG-RCT-2025-01
- Conditions
- Preterm Labour, Cervical Insufficiency, Pregnancy, High-Risk
- Keywords
- Interventions, Population, Study design, Clinical focus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 820 participants (actual)
- Lead sponsor
- Hina MukhtarUniversity, hospital or other
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preterm labour is a major cause of neonatal morbidity and mortality worldwide. Progesterone supplementation is known to help reduce the risk of preterm birth in high-risk women. This randomized controlled trial compared the effectiveness of intramuscular progesterone and rectal progesterone in preventing preterm labour among pregnant women who had undergone cervical cerclage. The study aimed to determine which route of progesterone administration provides better pregnancy prolongation and improved neonatal outcomes.
Detailed description
Background:
Preterm labour remains one of the leading causes of perinatal mortality and long-term neonatal complications. Cervical insufficiency, often managed by cervical cerclage, is a recognized risk factor for preterm birth. Progesterone supplementation helps maintain uterine quiescence and cervical integrity, but the optimal route of administration after cerclage is not well established.
Objective:
To compare the efficacy of intramuscular progesterone versus rectal progesterone in preventing preterm labour among women who underwent cervical cerclage.
Methods:
This single-centre, randomized controlled trial was conducted in the Department of Obstetrics \& Gynecology, Bahawal Victoria Hospital, Bahawalpur, Pakistan. Eligible women with singleton pregnancies who had undergone cervical cerclage were randomly assigned to receive either weekly intramuscular progesterone (250 mg) or daily rectal progesterone suppositories (400 mg) from 16 to 36 weeks of gestation. The primary outcome was the incidence of preterm labour before 37 weeks. Secondary outcomes included gestational age at delivery, neonatal birth weight, NICU admission, and maternal side effects.
Significance:
This study provides evidence on the comparative effectiveness of two commonly used routes of progesterone administration in women with cerclage, aiming to identify the safer and more convenient regimen for prolonging pregnancy and improving neonatal outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramuscular Progesterone Group | Experimental | Drug: Intramuscular Progesterone, Drug: Rectal ProgesteroneParticipants in this group received intramuscular progesterone (hydroxyprogesterone caproate) 250 mg once weekly, starting from 16 weeks until 36 weeks of gestation, following cervical cerclage. The injections were administered in the gluteal region under aseptic conditions. The purpose of this intervention was to maintain uterine quiescence and reduce the risk of preterm labour in high-risk pregnancies after cerclage. |
| Rectal Progesterone Group | Experimental | Drug: Intramuscular Progesterone, Drug: Rectal ProgesteroneParticipants in this group received rectal progesterone suppositories 400 mg once daily, starting from 16 weeks until 36 weeks of gestation, following cervical cerclage. The suppositories were self-administered at bedtime. The aim of this intervention was to provide sustained progesterone support for maintaining uterine relaxation and reducing the risk of preterm labour after cerclage. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women aged 18-45 years
- Singleton pregnancy
- Gestational age between 16 and 24 weeks at enrollment
- Diagnosed with cervical insufficiency and scheduled for or recently undergone cervical cerclage
- Willing to receive progesterone therapy and provide written informed consent
Key exclusion criteria (8 listed)
- Multiple pregnancy
- Known fetal anomalies
- Severe maternal comorbidities (e.g., hypertension, diabetes, cardiac disease)
- History of allergy or hypersensitivity to progesterone or related compounds
- Contraindications to progesterone use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramuscular ProgesteroneHydroxyprogesterone caproate 250 mg administered intramuscularly once weekly from 16 to 36 weeks of gestation following cervical cerclage. Used to maintain uterine quiescence and prevent preterm labour. | Drug | Intramuscular Progesterone Group, Rectal Progesterone Group |
| Rectal ProgesteroneMicronized progesterone 400 mg suppository administered rectally once daily from 16 to 36 weeks of gestation following cervical cerclage. Intended to provide sustained progesterone support and prevent preterm labour. | Drug | Intramuscular Progesterone Group, Rectal Progesterone Group |
Primary outcome
Frequency of Preterm Birth (<37 Weeks)
Time frame: 16-36 weeks until delivery
5 secondary outcomes
Gestational Age at Delivery
Time frame: At delivery
Neonatal Birth Weight
Time frame: At birth
Apgar Scores at 1 and 5 Minutes
Time frame: Immediately post-delivery
NICU Admission Rate
Time frame: Within 24 hours of birth
Maternal Adverse Effects
Time frame: During treatment period (16-36 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Preterm Labour
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Cervical Stiffness in Women With Threatened Preterm Labor
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Intravenous Papaverine for Term Prelabor Rupture of Membranes
Premature Rupture of Fetal Membranes
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Maternal Stress on Human Milk and Infant Outcomes
Postpartum Depression, Preterm Labor
Active, not recruitingObservational study
Is the Vaginal Microbiome and Metabolome Associated With Spontaneous Preterm Birth (sPTB) in Multiple Pregnancies?
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IL-6 and Lactates in Cord Blood and Neonatal Outcomes
Fetal Infection, Fetal Inflammatory Response Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hina Mukhtar, MBBS principal investigator
CMIS Bahawalpur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intramuscular Progesterone and Rectal Progesterone in people with Preterm Labour and Cervical Insufficiency, run by Hina Mukhtar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Preterm Birth (<37 Weeks) (time frame: 16-36 weeks until delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.